The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving “over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law.”  The warning letter includes multiple violations considering third-party supply chain manufacturers.“Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk.  Americans expect and deserve drugs that are safe, effective and that meet our standards for quality.  The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans.  We will remain vigilant in our efforts to protect the U.S. public from companies who put the health of Americans at risk – whether through the manufacturing and distribution of products we regulate or other means.”

Photo by Phuong Tran on Unsplash

The warning letter focuses on adulterated drugs from manufacturers that received FDA warning letters in 2018.  The foreign manufacturers from which the Dollar Tree accepted products previously received warning letters and were placed on import alert.  The Dollar Tree, according to the FDA, has shown “a pattern of serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality.”The official warning letter states, in part, “Import records reviewed indicated that your firm received Acne Treatment Pads and (b)(4) from Shanghai Weierya Daily Chemicals Factory, FEI 3010166363, on October 9, 2017 and November 3, 2017, respectively.  An inspection of Shanghai Weierya Daily Chemicals in April of 2017 revealed significant CGMP violations, including the failure to conduct component identity testing (21 CFR 211.84(d)(1)) and the failure to test each batch of drug for objectionable microorganisms prior to distribution (21 CFR 211.165(b)).  As a result of these and other violations, Shanghai Weierya Daily Chemicals was placed on lmport Alert 66-40 on September 14, 2017 and issued a warning letter on February 7, 2018. FDA copied your Chief Operating Officer (COO) on the outgoing warning letter….Import records reviewed indicated that your firm received various (b)(4) and (b)(4) drug products from Hangzhou Zhongbo Industrial Company, Ltd., FEI 3008229416, from October through December of 2018.  An inspection of Hangzhou Zhongbo Industrial Company, Ltd. in April of 2018 revealed significant CGMP violations, including the failure to test each batch of drug for conformance with specifications prior to release (21 CFR 211.165(a)).  As a result of this and other violations, Hangzhou Zhongbo lndustiial Company, Ltd. was placed on Import Alert 66-40 on September 28, 2018 and was issued a warning letter on November 27, 2018. FDA copied your COO on the outgoing warning letter…Considering that FDA has found a pattern of drug manufacturers with serious CGMP violations in your supply chain, in response to this letter, provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce, in violation of section 301 (c) of the FD&C Act, 21 U.S.C. 331(c).”

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FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugsWARNING LETTER: Greenbrier International, Inc dba Dollar Tree